1A. cGMP

1967

WHO the drafted GMP on the manufacture and quality control of medicines and pharmaceuticals upon the request of 20th World Health Assembly

1968

the draft was revised, adapted and published as annex to the 22nd report

1971

it was reproduced in the Supplement to the 2nd edition of the International Pharmacopo eia

GMP (Good manufacturing practice)

is everyone’s responsibility

Quality

The Quality of a formulation or a bulk drug depends on the __ of those producing it

GMP (Good manufacturing practice)

is the magic key that opens the door of the Quality ▪

GMP (Good manufacturing practice)

In matter of __, swim with the current!

Quality

In matter of __, stand like a rock!

GMP - “Good Manufacturing Practice”

cGMP - “Current Good Manufacturing Practice”

both terms can be used interchangeably since they are essentially the same

GMP - “Good Manufacturing Practice”

cGMP - “Current Good Manufacturing Practice”

both guidelines gives highest priority to the protection of the public health

GMP - “Good Manufacturing Practice”

cGMP - “Current Good Manufacturing Practice”

both regulations also define minimum requirements

GMP

older version of guidelines

cGMP

newer version of guidelines

because cGMP already contains guidelines that are applicable in these present times due to new technology and concept ( innovations, changes & improvements) use and applied in manufacturing therefore the need to revised the main GMP principle was necessary

how GMP and cGMP differs?

GMP (Good manufacturing practice)

set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.

GMP (Good manufacturing practice)

part of Quality Assurance, which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization, or product specification.

GMP (Good manufacturing practice)

involves both production and QC

GMP (Good manufacturing practice)

to ensure the Quality, Safety, and Efficacy of products

GMP (Good manufacturing practice)

a basic tenet of this is that quality cannot be tested into a batch of the product but must be built into each batch of a product during all stages of the manufacturing process

GMP (Good manufacturing practice)

it is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product

cGMP (Current Good Manufacturing Practice)

also the main regulatory standard for ensuring pharmaceutical QUALITY

cGMP (Current Good Manufacturing Practice)

"current," requiring companies to use up-to-date technologies and systems to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, deviations, failures, and errors 10 or 20 years ago may be less than adequate by today's standards.

cGMP (Current Good Manufacturing Practice)

requirements established that permit flexibility to every manufacturer to decide individually how to implement the necessary best and even the best controls for their organization by using scientifically sound design, processing methods, control of manufacturing process and facilities, and testing procedures.

cGMP (Current Good Manufacturing Practice)

the flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher product quality through continual improvement.

Definition of cGMP according to Title 21 Code of Federal Regulations (CFR), Part 210.1

“The minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess”

✓Unexpected contamination of products, causing damage to health or even death.

✓Incorrect labels on containers, which could mean that patients receive the wrong medicine ✓Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects

The main risks are :

unexpected contamination of products

causing damage to health or even death.

incorrect labels on containers

which could mean that patients receive the wrong medicine

insufficient or too much active ingredient

resulting in ineffective treatment or adverse effects

Importance of GMP and cGMP

the guidelines are enacted to ensure food, drugs, cosmetics, medical devices and related products have no harmful substances.

FDA

Importance of GMP and cGMP: These regulations, enforced by the __, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.

poor quality medicine

may contain toxic substances that have been unintentionally added

little or none

A medicine that contains__of the claimed ingredient will not have the intended therapeutic effect

cGMP regulations

Adherence to the ___ assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations every step

Importance of GMP

achieve consistency in product production and quality control

GMP (Good manufacturing practice)

helps boost pharmaceutical export opportunities. ➢ most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP

Good clinical practice and CGMPs

There are many aspects of compliance with ___ as required by the FDA.

cGMP compliance

upon the inspection of the FDA, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained FDA staff.

fully compliant

If the manufacturer has no issues and has fully complied with all aspects or areas of CGMP regulations and standards, then the manufacturer is found to be__

compliance

determination through inspection of the content to which a manufacture is acting in accordance with prescribed regulations, standards and practices

cGMP Non-Compliance

the FDA found during the conduct of inspection of the manufacturer any slight issues, problem and deviance or not following in even aspect or areas of the CGMP regulations then FDA has the authority to issue warning letters and reports detailing areas of ___

cGMP Non-Compliance

subsequently, these areas highlighted must be corrected within a suitable timeframe, or a company’s products will not be approved for sale into the market.

adulterated

any drug it makes is considered __ under the law. this kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the drug.

1. Policies

2. SOP (Standard Operating Procedure)

3. Specifications

4. MFR (Master Formula Record)

5. BMR (Batch Manufacturing Record)

6. Manuals

7. Master plans/ files

8. Validation protocols

9. Forms and Formats 10.Records

List of important documents in GMP

Phil. CGMP

was a government mandate issued under A.O. no. 43 s. 1999

Phil. CGMP

addressed to all manufacturing companies, distribution companies, traders, and wholesalers

Phil. CGMP

adopted and included all the basic guidelines stated or found in the WHO CGMP applicable to Phil. setting

Phil. CGMP

issued under the authority of the gov't Secretary of Health

Phil. CGMP

adopted to: prescribe standard guidelines in the manufacture of drug products

Phil. CGMP

adopted to: ensure that no person or establishment shall manufacture drugs under substandard conditions.

Part 1: General Provision - 4 sections

Part 2: Basic GMP guidelines - 12 sections

Part 3: Guidelines on Sterile Products - 15 sections

Phil. CGMP consists of 3 parts mainly

General Provision - 4 sections

Part 1 of Phil. cGMP

Basic GMP guidelines - 12 sections

Part 2: of Phil. cGMP

Guidelines on Sterile Products - 15 sections

Part 3 of Phil. cGMP

Responsibility for Quality

Personnel Qualifications

Production & Process Controls

Comparison of GMPs (US, WHO, EU )

FDA

Responsibility for Quality ;the QC unit is responsible for quality

WHO & EU

Responsibility for Quality; define both separate and joint responsibilities for the QC unit and production management

FDA

Personnel Qualifications ; education, knowledge, skills, or experience needed for specific job functions are not defined

WHO & EU

Personnel Qualifications ; – provide such definitions & requirements

FDA

Production & Process Controls ; focuses on levels of approval

ICH

Production & Process Controls; focuses on stability requirements

General Provision

GMP guidelines

Guidelines on Sterile Products

3 parts and sections of Phil. cGMP

1. Authority

2. Statement of Policies

3. Statement of Objectives

4. Definition of Terms

General Provisions (4)

1. Personnel

2. Premises

3. Equipment

4. Sanitation & Hygiene

5. Storage of Starting & Packaging materials, intermediates bulk products and finished products 6. Production

7. Packaging

8. Finished Product Quarantine and Delivery to warehouse

9. Quality Control

10. Documentation

11. Self-Inspection

12. Guidelines for handling product complaint, recall and return

GMP guidelines (12)

1. General Characteristics

2. Personnel

3. Clothing

4. Cleanliness & Hygiene

5. Premises

6. Equipment

7. Production

8. Processing

9. Sterilization

10. Validation requirements for sterilization process 11. Water

12. Filtration of pharmac'l products that cannot be sterilized on their container

13. Finishing of Sterile Products

14. Biological & Chemical Indicators

15. Quality Control

Guidelines on Sterile Products (15)

quality assurance

it is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use

quality assurance

All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality

quality control

is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out

control

Operational laboratory techniques and activities used to fulfill the requirement of Quality

quality assurance

company based

quality control

lab based

quality assurance

prevention

quality assurance

planning first to avoid the defect or error from occuring

quality assurance

process-based approach

quality assurance

involves processes managing quality

quality control

detection

quality control

finding defects and correcting them whole making the product

quality control

product-based approach

quality control

involves verifying the quality of the product